FDA Takes Step Toward FSVP Enforcement With New Import Alert
The Food and Drug Administration looks set to ramp up enforcement of Foreign Supplier Verification Program requirements for food importers, after creating a new import alert on July 31 for importers that aren’t compliant with the regulations. Import Alert 99-41 provides for FDA detention without physical examination of human or animal food offered for import by importers listed on the import alert’s red list. No importers have been listed as of press time.
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Importers may be added to the red list if it “appears that the importer is not in compliance with FSVP requirements for one or more foods,” the import alert says. The import alert may apply to all foods imported by that importer, or just a subset identified on the red list. Each listing may identify the foreign supplier, but does not apply to all food produced by the foreign supplier; rather, it applies only to food from that foreign supplier that is imported by the red-listed importer.
If listed, importers will have to request that FDA remove them from the red list, and must submit information that they have “resolved the conditions that gave rise to the appearance of the FSVP violation,” the importer said. Foreign suppliers are not responsible for demonstrating that an importer should be removed from the red list, but they may contact FDA offices to seek information about removal. “If this occurs, the FDA offices should direct the foreign suppliers to contact the relevant importers,” the import alert says.
The new import alert marks a “critical step towards enforcement of FSVP, according to an Aug. 6 blog post from fdaimports.com. “It remains unforeseen when FDA will place the first importer on Import Alert 99-41, thereby taking the first enforcement action. However, now with the import alert created, it is only a matter of time,” the blog post said. “To date, FDA has not taken any enforcement action against an importer for not complying with the regulations, which first went into effect May of 2017. However, that may change soon,” fdaimports.com said.